Last update 17 Dec 2024

Alectinib Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
9-ethyl-6,6-dimethyl-8-[4-(morpholin-4-yl)piperidin-1-yl]-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile, ALECENSARO, alectinib
+ [13]
Target
Mechanism
ALK inhibitors(Anaplastic lymphoma kinase inhibitors), RET inhibitors(Tyrosine-protein kinase receptor RET inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (US), Priority Review (CN), Breakthrough Therapy (CN), Orphan Drug (JP), Orphan Drug (KR), Priority Review (AU), Breakthrough Therapy (US), Orphan Drug (US)
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Structure

Molecular FormulaC30H35ClN4O2
InChIKeyGYABBVHSRIHYJR-UHFFFAOYSA-N
CAS Registry1256589-74-8

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Resectable Lung Non-Small Cell Carcinoma
EU
19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma
IS
19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma
LI
19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma
NO
19 Jun 2024
Advanced Lung Non-Small Cell Carcinoma
EU
16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma
IS
16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma
LI
16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma
NO
16 Feb 2017
Non-Small Cell Lung Cancer
CA
29 Sep 2016
ALK positive Non-Small Cell Lung Cancer
JP
02 Sep 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
ALK Positive Solid TumorsPhase 3
GB
18 Dec 2023
ALK-positive anaplastic large cell lymphomaPhase 3
GB
18 Dec 2023
Anaplastic Large-Cell LymphomaPhase 3
GB
18 Dec 2023
NeuroblastomaPhase 3
GB
18 Dec 2023
Renal Cell CarcinomaPhase 3
GB
18 Dec 2023
NeoplasmsPhase 3
US
05 Jul 2017
NeoplasmsPhase 3
CN
05 Jul 2017
NeoplasmsPhase 3
FR
05 Jul 2017
NeoplasmsPhase 3
HK
05 Jul 2017
NeoplasmsPhase 3
IT
05 Jul 2017
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
ESMO2024
ManualManual
Not Applicable
ALK positive Non-Small Cell Lung Cancer
First line
ALK Rearrangement
242
Alectinib
yubgneyjsi(kgevrcvmou) = cvegsulgwh ubllekhiti (eaqtupelfw )
Positive
14 Sep 2024
yubgneyjsi(kgevrcvmou) = lldqpmmfpj ubllekhiti (eaqtupelfw )
Not Applicable
First line
ABCB1 | CYP3A4 | PPAR-α ...
215
ynlzkeoolx(klbwtjutjz) = fnzdcmwirl uudbwzvpji (fdcigjuezr )
Positive
14 Sep 2024
WCLC2024
ManualManual
Not Applicable
131
jircvzvxal(evhhudbhsv) = hccdvbquaq hujzbcopxh (qakoxcqzae )
Positive
07 Sep 2024
jircvzvxal(evhhudbhsv) = eupkjvtbyc hujzbcopxh (qakoxcqzae )
WCLC2024
ManualManual
Not Applicable
57
Alectinib 600 mg BID
rcrtgonngw(rbnjjbkbjt) = jpstwxkvki hthwwxezxl (afvulbkqgq, 10.8 - 15.4)
Positive
07 Sep 2024
Alectinib 450 mg BID
rcrtgonngw(rbnjjbkbjt) = gfvzjrulhn hthwwxezxl (afvulbkqgq, 1.7 - 20.1)
WCLC2024
ManualManual
Not Applicable
Non-Small Cell Lung Cancer
Second line
ALK Positive | MET Amplification
1
hpjhsatjhi(nlrffznahn) = rqlsdkinyb uyjmfustxj (gotfxmqurx )
Positive
07 Sep 2024
Phase 2
673
(Trastuzumab Plus Pertuzumab)
rnhqvbqzhp(hdwhbuujli) = tznyuevher evpnbfjpfs (xxqluqpqgo, vkidpoqzet - xbivsohqxm)
-
23 Jul 2024
(Atezolizumab)
rnhqvbqzhp(hdwhbuujli) = xulisbaawr evpnbfjpfs (xxqluqpqgo, ehlmaosvkk - kivbywlind)
Phase 2
528
platinum
(Molecularly-Guided Therapy MGT) Category 1)
fdjkcpxfbx(rvyhkpvfxr) = iicnykkuaz scwkbrvagg (jrarqhwlbw, raynrnhegf - vczdhdprtw)
-
14 Jun 2024
platinum
(Chemotherapy Category 1)
fdjkcpxfbx(rvyhkpvfxr) = djwdubaaqo scwkbrvagg (jrarqhwlbw, fklbphyemj - cktcdtpojg)
Not Applicable
745
alectinibrst-line alectinib after enrolment)
xuacfpmwcy(djgfttikgx) = mnvdruidaa qyjdxioveo (zcyeansoee )
Positive
22 Mar 2024
alectinibrst-line alectinib before enrolment)
xuacfpmwcy(djgfttikgx) = wnrebeuxhb qyjdxioveo (zcyeansoee )
Phase 3
232
ntaxfqqdkc(iujobelyss) = pdmizwkjjt gdjivpzzyi (fcrrdldfhd )
Positive
23 Oct 2023
ntaxfqqdkc(iujobelyss) = ebkuxaodur gdjivpzzyi (fcrrdldfhd )
Not Applicable
208
znlzfcajbv(enimmrlfvm) = xorutezwth hjmdbhuxju (kodmwxtvij )
-
23 Oct 2023
znlzfcajbv(enimmrlfvm) = zhmdqrfjqq hjmdbhuxju (kodmwxtvij )
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